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Completed

NCT Number: NCT01208753

Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Stuivenberg

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male, age 18-50 years
  • BMI between 18-30 kg/m², inclusive.

Exclusion criteria

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse

Treatment and study plan

GLPG0555

Drug

two different aqueous formulations

GLPG0555 aqueous

Drug

multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined

Placebo

Drug

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Primary outcomes

  1. Safety and tolerability of multiple dosing

    Time frame: Daily during treatment, up to 10 days postdose

Secondary outcomes

  1. Pharmacokinetics of repeated doses

    Time frame: 24 hours postdose

  2. Pharmacodynamics (PD) of GLPG0555 after repeated oral administration

    Time frame: up to 10 days postdose

  3. The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days

    Time frame: up to 24 hours postdose

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 in Healthy Subjects.

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Sep 24, 2010
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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